Biostatistics Analysis Center Overview and Services BAC Executive

Biostatistics Analysis Center Overview and Services BAC Executive Committee Warren Bilker, Ph. D John Farrar, MD, Ph. D Michael Kallan, MS Scott Appel, MS September 24, 2020

Overview and Mission Providing timely, high-quality biostatistical analysis and programming to the University of Pennsylvania research community

The Basics The BAC currently consists of 11 biostatisticians and 2 programmers, and expects to continue growing. In Fiscal Year 2020, we worked on approximately 100 projects (about half of which were new during FY 20), bringing in a total revenue of over 2 M. In 2021, the team continues working with a diverse group of investigators.

BAC Organizational Chart Harold Feldman, Ph. D Director, CCEB Glen Lafferty Director, Fiscal and Administrative Operations Warren Bilker, Ph. D Professor and Director, BAC Scott Appel Co-Director, BAC Ann Tierney Manager, Senior Biostatistician Qing Liu Application Developer Lynne Taylor Senior Biostatistician Xiaoyan (Sherry) Han Biostatistician Colleen Brensinger Senior Biostatistician Min Du Application Developer John Farrar, MD/Ph. D Associate Professor and Director, BAC Michael Kallan Co-Director, BAC Craig Newcomb Senior Biostatistician Peter Preston Biostatistician Xingmei Wang Biostatistician Qufei Wu Biostatistician Tara Mc. Williams Statistical Analyst

Working with the BAC u Initial Consults Are Fast and Free o Contact us through this link https: //www. cceb. med. upenn. edu/bac/contact-us or by searching Penn BAC o We reply to consult requests no later than the next business day o The initial meeting can be scheduled as promptly as the investigator would like o After the initial meeting, the BAC will work towards quickly setting up the scope of work and corresponding budget o FY 21 rates are lower than FY 20 rates, and are highly competitive with most biostatistical consultation groups u We work on projects and grants of all sizes and complexities

Summary of Services u Biostatistical Analysis and Programming o Primary statistical analysis o Creation/handling of large medical record and administrative databases, including Penn Data Store o Development and production of monitoring reports for clinical studies o Development of publication-quality tables and graphs for manuscripts, posters, and other presentations o Independent manuscript review and analysis verification u Collaboration on Study Design and Grant/Proposal Development o Development and implementation of study designs (all sizes and complexity) o Sample size/power calculations o Development of analytic scope of work and budget estimates for inclusion in grant proposals u Data Management/Data Cleaning

Benefits of Working With the BAC u Masters-trained analysts with a wide range of skills and expertise, most of whom have been working for the BAC for over ten years u Flexible contracting allows for either standalone projects, ongoing collaboration with a department, or purchasing a percentage of a BAC member’s time u Can call upon expertise of Dr. Bilker and Dr. Farrar as needed u Reproducible, documented analyses u Ability to ramp up effort rapidly u Duplicate analyses when requested u Access to a large library of efficient sample code u Close working relationship with the CRCU on clinical studies

Some Departments Supported by the BAC Schools o o o Dental Medicine Social Policy and Practice Medicine Wharton Nursing Veterinary Medicine Departments Within the School of Medicine o o o o o Anesthesiology and Critical Care Cardiovascular Medicine Dermatology Emergency Medicine Gastroenterology General Internal Medicine Infectious Diseases Obstetrics and Gynecology Orthopedic Surgery Pathology and Laboratory Medicine Pediatrics Pulmonary and Critical Care Neurology Psychiatry Radiation Oncology Rheumatology Urology

Examples (of Larger Studies) Project Investigator(s) Funding Source Length of Study Drug-Drug Interactions Hennessy/Leonard NIH Multiple projects, many years Dermatology Margolis/Gelfand Department 5 th year, ongoing FMT Registry Support Lewis NIH 4 th year REGAIN Neuman PCORI 6 th year CART-19 June Novartis 7 th year MAPP Landis NIDDK 13 th year T-Trials Snyder NIH 12 th year American Heart Assoc. AHA 13 years, ongoing

Detailed Examples (1) u Pharmacoepidemiology large database studies of adverse drug effects o Analytic plan defined by the faculty biostatistician o Statistical programming and analyses carried out by an experienced BAC team, with programmers following the direction of the senior-level BAC biostatistician u National multi-center studies with biostatistics faculty co-investigators directing a BAC team (e. g. , MAPP, REGAIN, T-Trials) o Under the direction of the biostatistics faculty member, the BAC: § Develops and produces regular monitoring reports § Performs interim and ad hoc analyses § Produces presentations at project meetings, DSMB meetings, and SCMs o Increased efficiency from longstanding close working relationship with the CRCU

Detailed Examples (2) u General support for medical departments or divisions o Accommodates unfunded analytic needs of junior faculty and fellows o Departmental funding for a dedicated BAC analyst to support preparation of grants, analyses of trial data for publication, posters, or conference presentations u Data management and biostatistical programming and analysis support for national registries (e. g. , American Heart Association Get With the Guidelines – Resuscitation). o o Preparation of annual analytic databases Analytic support for multiple manuscripts Support for ad hoc requests from AHA and other investigators Central contact for merges of AHA data and data from other registries or administrative databases, including American Hospital Association and CMS

Contact Us u BAC online collaboration request form on our website: https: //www. cceb. med. upenn. edu/bac/contact-us u CCEB grant registration form: http: //www. med. upenn. edu/ccebtest/grantreg_form. html u Staff contacts: Scott Appel: appelsc@pennmedicine. upenn. edu or 215 -573 -8391 Michael Kallan: mkallan@pennmedicine. upenn. edu or 215 -573 -4594 u Faculty contacts: Warren Bilker: warren@pennmedicine. upenn. edu or 215 -898 -1619 John Farrar: jfarrar@pennmedicine. upenn. edu or 215 -898 -5802

www. upennbac. org